Senior Analyst I, Quality Control Chemistry

A recognized company is looking to hire a Senior Analyst I, QC Chemistry on a long-term contract basis. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs).

***This role is 100% onsite in Woburn, MA.**

Responsibilities

• Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)
• Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
• Support and lead QC Chemistry laboratory operations (ex. Instrument qualification and maintenance, ousekeeping, qualify critical reagents, etc).
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods.
• Perform other duties, as needed

Qualifications:

• 5 years of experience working in a cGMP environment.
• Bachelor's and/or Master's Degree in Analytical Chemistry, Biochemistry, Biophysics, or a related discipline
• Experience working in the cGMP QC lab of the Pharmaceutical or Biopharmaceutical industry
• Strong collaboration and team-working skills
• Strong communication, interpersonal and organizational skills
• Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines

Desired Skills:

• Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS
• Experience working with external contract labs (CMOs, CROs)